MDR Labeling - Explained!

Daniel Laufersweiler
October 14, 2022
Medical Device Regulation

Far too often, labeling under the MDR is examined too casually and not implemented 100%. We experience again and again that products already marketed under the MDR still have many label errors. Especially manufacturers of class I products still have gaps here, which can become an issue during inspections at the latest. Of course, this can be noticed earlier. After all, the labels are the figurehead of every product. Even worse: If certain requirements are visibly not implemented on the label, this implies a deficient MDR implementation and wakes sleeping wolves.

Don't leave your labeling to chance. Implement the MDR requirements or check your current status.

Do I need a label process?

How can I show that I have implemented all the requirements for my label? Of course: with a process. But actually living a good process is another challenge. A good digital label process ensures versioning and thus also quality.

MDR example label

The worst case example label shown here has the requirements collected on one label. Take a closer look at the references to ANNEX I (GSPRs). Here, one or the other may notice that requirements have not yet been sufficiently documented in the GSPR document.

-> DOWNLOAD LABELS

Attention: Not everything you see here has to be on your label! It depends on the requirements.

Best Practice Tip!

Go through requirement by requirement and document the current status and the changes that need to be made to the label. Be sure to not only review Annex I requirements, but also include standards such as ISO 15223-1:2021.

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